Pharmacovigilance GCP Auditor

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Abbott is a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Abbott products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. Our comprehensive line of products encircles life itself - addressing important health needs from infancy to the golden years. Abbott employs over 65,000 professionals who bring their passion to life in Abbott labs and offices across the globe. Abbott's corporate headquarters, located north of Chicago, near Waukegan, Illinois, has great career opportunities for experienced Pharmacovigilance GCP Auditors to join Abbott's Global Pharmaceutical R&D division. Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company-paid pension plan and a profit sharing plan, all with a company providing the growth and strength to build your future! Responsible for the global assessment of Quality Systems within the Global Pharmaceutical R&D/Abbott International environments. Identify potential regulatory compliance gaps through the conduct of internal domestic and international pharmacovigilance system audits worldwide. Also conduct external GCP audits of clinical investigator sites. Evaluates overall compliance to Abbott policies, ICH Guidelines, country-specific regulations, and other applicable regulations and standards.Responsible for assessing GCP/ Pharmacovigilance compliance for regulated documents, such as protocols, investigator brochures, clinical study reports, periodic safety update reports (PSURs)etc. Generates reports utilizing computers/databases and participates in regulatory compliance and quality improvement initiatives. Provides consultation and assistance on compliance issues to GPRD and international affiliate personnel. Reviews corrective action plans/audit responses. Effectively interacts with applicable personnel to achieve effective GPRD operations and compliance with worldwide regulatory requirements. Domestic/international travel will be approx. 30-40%.QualificationsProfessional experience in nursing or pharmacy. Demonstrated knowledge and experience in clinical research, pharmacovigilance, and/or compliance auditing essential. Bachelor's degree; specialization in nursing or pharmacy.Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.